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RECRUITINGPhase 2INTERVENTIONAL

A Phase 2 Study of HB0017 in Psoriasis Patients

A Multicenter, Randomized, Double-blind Phase 2 Clinical Study Evaluating the Efficacy and Safety of Different Administration Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female subjects aged 18-75 years (inclusive) - Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomization. - Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3. - Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator - Subjects who are able to use effective contraception from the screening period to 6 months after the last dose Who Should NOT Join This Trial: - Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline Drug-induced psoriasis - Ongoing use of prohibited treatments - Any active infection (other than common cold) within 14 days - Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization - Have previously received any drug that directly targets IL-17 or IL-17 receptor - Have concurrent or recent use of any biologic agent within the following waiting period after previous treatments: etanercept \<28 days; infliximab and adalimumab \<60 days; golimumab \< 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \<6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization - A history of inflammatory bowel disease or other serious autoimmune conditions (where your immune system attacks your own body) - Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Male or female subjects aged 18-75 years (inclusive) * Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomization. * Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3. * Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator * Subjects who are able to use effective contraception from the screening period to 6 months after the last dose Exclusion Criteria: * Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline Drug-induced psoriasis * Ongoing use of prohibited treatments * Any active infection (other than common cold) within 14 days * Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization * Have previously received any drug that directly targets IL-17 or IL-17 receptor * Have concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab and adalimumab \<60 days; golimumab \< 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \<6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization * A history of inflammatory bowel disease or other serious autoimmune disease * Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency

Treatments Being Tested

BIOLOGICAL

HB0017

300mg Q12W

BIOLOGICAL

HB0017

300mg Q8W

BIOLOGICAL

HB0017

150mg Q4W

Locations (18)

The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China
Jilin University Second Hospital
Changchun, Jilin, China
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, China
Jining First People's Hospital
Jining, Shandong, China
Xingtai People's Hospital
Xingtai, Shandong, China
Shanxi Medical University Second Hospital
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China
Guangdong Provincial People's Hospital
Guangzhou, China
Ningbo Second Hospital
Ningbo, China